Sunday, September 05, 2010

Here are some frequantly asked questions about clinical trials.

 

What is a clinical trial?

Since its founding in 1906, the Food and Drug Administration has been responsible for developing safe and effective new medical treatments including medicines and medical devices.

Such development programs cannot be done using animals only. Human volunteers are required to provide information regarding the potential safety and effectiveness of new medicines. In order to do so, medical scientists design appropriate experiments to test safety and effectiveness. These experiments are called clinical trials or clinical studies.

Clinical trials are conducted on treatments intended to prevent diseases such as vaccines. Other clinical trials may assess a combination of two or more treatments or to control symptoms. Many clinical trials are designed to measure the safety of an already-approved treatment over long periods of time.

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What are the benefits of volunteering to participate in a clinical trial?

Without volunteers new treatments cannot be developed for future. First and foremost, all participants receive a free consultation and second opinion regarding the disease or disorder and the treatments being tested at no obligation.

If you join a clinical trial, ongoing medical evaluations such as physical examinations, laboratory tests, EKGs and others will be conducted to monitor your general health and well-being.

Finally, there is a possibility that the medicine or treatment being tested may relieve your disease or symptoms.

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What are the risks associated with participating in clinical trials?

Risk is present in using all medical treatments including medicines and devices. Clinical trials are designed to assess these risks before any medicine is approved for general use in America.

Since not all risks are known when testing new medical treatments, medical ethics committees review all new clinical trials and require that all potential patients/subjects are fully made aware in writing (called written informed consent) of all risks that are known to be associated with the test medicine or device.

Additionally, all new information regarding safety must to be presented in writing so that participants are fully aware of new risks as they become known. It is the right of each participant to join a trial voluntarily or to continue in a trial based on up-to-date information about risks.

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How much will it cost to participate in a clinical trial?

There is no cost to those who volunteer to participate in a clinical trial. In most clinical trials there will be some monetary compensation to cover the incidental cost for gas, parking and other expenses incurred by enrolled participants.

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What kind of care will I receive?

Clinical trials require experts in specific fields to conduct each trial. For example, new heart medications usually require a cardiologist to conduct the trial. Psychiatric medication trials, such as those conducted at NWCRC, require trained psychiatrists and psychologists.

Clinical trials will provide medical care and related benefits in the unlikely event you are harmed by participating in a clinical trial, as highlighted in the written informed consent.

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How long do the studies last?

Clinical trials can range in length from few weeks to one or more years depending on each situation. Follow-up care to achieve stabilization post-participation in a trial is available for one to two months, on a case by case basis at no cost to you.

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How can I volunteer to participate in a research study?

Contact us to find out if you may qualify to participate in a clinical trial. Call (877) 453-0404 or use the form to send us an email message.

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